Implant Direct Recalls Swish Tapered Implants Due to Packaging Error
Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging error (incorrect position of the extender) rather than a direct structural defect or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 1,117 units of Swish Tapered Implants. These devices are intended for use in support for fixed bridgework. The recall was initiated because the extender packaged with the implant may have been placed in the incorrect position, specifically upside down in the plastic retainer.
The affected products were distributed worldwide, including in the United States, Europe, Canada, Australia, and Japan. The recall covers specific part and lot numbers, including 934106, 934112, 934806, 934812, 934814, and 935712.
Healthcare professionals and patients should check their inventory or records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased.
The recalled product
- Product
- SwishTapered Implant Intended for use in support for fixed bridgework.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 1,117
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Part No. (Lot No.): 934106 (68075
- 69252
- 79574)
- 934112 (69101
- 80912)
- 934806 (68076
- 75219)
- 934812 (68078
- 68889)
- 934814 (67980)
- and 935712 (68077).
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Implant Direct Sybron Manufacturing, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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